Institution
European Medicines Agency
Government•Amsterdam, Netherlands•
About: European Medicines Agency is a government organization based out in Amsterdam, Netherlands. It is known for research contribution in the topics: European union & Clinical trial. The organization has 599 authors who have published 796 publications receiving 22281 citations. The organization is also known as: European Agency for the Evaluation of Medicinal Products & EMA.
Papers published on a yearly basis
Papers
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University of Tübingen1, World Health Organization2, University of Cape Town3, European Centre for Disease Prevention and Control4, Utrecht University5, Tel Aviv University6, Laval University7, Boston University8, Centers for Disease Control and Prevention9, European Medicines Agency10, Food and Drug Administration11, Biomedical Advanced Research and Development Authority12, University of Melbourne13, University of Otago14, George Washington University15
TL;DR: Future development strategies should focus on antibiotics that are active against multidrug-resistant tuberculosis and Gram-negative bacteria, and include antibiotic-resistant bacteria responsible for community-acquired infections.
Abstract: Summary Background The spread of antibiotic-resistant bacteria poses a substantial threat to morbidity and mortality worldwide. Due to its large public health and societal implications, multidrug-resistant tuberculosis has been long regarded by WHO as a global priority for investment in new drugs. In 2016, WHO was requested by member states to create a priority list of other antibiotic-resistant bacteria to support research and development of effective drugs. Methods We used a multicriteria decision analysis method to prioritise antibiotic-resistant bacteria; this method involved the identification of relevant criteria to assess priority against which each antibiotic-resistant bacterium was rated. The final priority ranking of the antibiotic-resistant bacteria was established after a preference-based survey was used to obtain expert weighting of criteria. Findings We selected 20 bacterial species with 25 patterns of acquired resistance and ten criteria to assess priority: mortality, health-care burden, community burden, prevalence of resistance, 10-year trend of resistance, transmissibility, preventability in the community setting, preventability in the health-care setting, treatability, and pipeline. We stratified the priority list into three tiers (critical, high, and medium priority), using the 33rd percentile of the bacterium's total scores as the cutoff. Critical-priority bacteria included carbapenem-resistant Acinetobacter baumannii and Pseudomonas aeruginosa , and carbapenem-resistant and third-generation cephalosporin-resistant Enterobacteriaceae. The highest ranked Gram-positive bacteria (high priority) were vancomycin-resistant Enterococcus faecium and meticillin-resistant Staphylococcus aureus . Of the bacteria typically responsible for community-acquired infections, clarithromycin-resistant Helicobacter pylori , and fluoroquinolone-resistant Campylobacter spp, Neisseria gonorrhoeae , and Salmonella typhi were included in the high-priority tier. Interpretation Future development strategies should focus on antibiotics that are active against multidrug-resistant tuberculosis and Gram-negative bacteria. The global strategy should include antibiotic-resistant bacteria responsible for community-acquired infections such as Salmonella spp, Campylobacter spp, N gonorrhoeae , and H pylori . Funding World Health Organization.
3,184 citations
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University of Barcelona1, Hacettepe University2, Cajal Institute3, European Medicines Agency4, University of Antwerp5, Brighton and Sussex Medical School6, GlaxoSmithKline7, Radboud University Nijmegen8, European Centre for Disease Prevention and Control9, Center for Disease Dynamics, Economics & Policy10, European Food Safety Authority11, University of Seville12, Southmead Hospital13, University College Dublin14, Aix-Marseille University15, Carlos III Health Institute16, University of Tübingen17, University of Warwick18
TL;DR: The views of the B-Debate participants regarding the current situation of antimicrobial resistance in animals and the food chain, within the community and the healthcare setting as well as the role of the environment and the development of novel diagnostic and therapeutic strategies are summarized, providing expert recommendations to tackle the global threat of antimacterial resistance.
Abstract: In the last decade we have witnessed a dramatic increase in the proportion and absolute number of bacterial pathogens resistant to multiple antibacterial agents. Multidrug-resistant bacteria are currently considered as an emergent global disease and a major public health problem. The B-Debate meeting brought together renowned experts representing the main stakeholders (i.e. policy makers, public health authorities, regulatory agencies, pharmaceutical companies and the scientific community at large) to review the global threat of antibiotic resistance and come up with a coordinated set of strategies to fight antimicrobial resistance in a multifaceted approach. We summarize the views of the B-Debate participants regarding the current situation of antimicrobial resistance in animals and the food chain, within the community and the healthcare setting as well as the role of the environment and the development of novel diagnostic and therapeutic strategies, providing expert recommendations to tackle the global threat of antimicrobial resistance.
803 citations
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Brighton and Sussex Medical School1, Université libre de Bruxelles2, Sunnybrook Health Sciences Centre3, Federal University of São Paulo4, University of Pittsburgh5, University Hospital of Lausanne6, Brown University7, The Feinstein Institute for Medical Research8, University of Amsterdam9, European Medicines Agency10
TL;DR: The understanding of the clinical epidemiology and management of sepsis is set out and how the present approaches might be challenged to develop a new roadmap for future research is asked.
Abstract: Sepsis is a common and lethal syndrome: although outcomes have improved, mortality remains high. No specific anti-sepsis treatments exist; as such, management of patients relies mainly on early recognition allowing correct therapeutic measures to be started rapidly, including administration of appropriate antibiotics, source control measures when necessary, and resuscitation with intravenous fluids and vasoactive drugs when needed. Although substantial developments have been made in the understanding of the basic pathogenesis of sepsis and the complex interplay of host, pathogen, and environment that affect the incidence and course of the disease, sepsis has stubbornly resisted all efforts to successfully develop and then deploy new and improved treatments. Existing models of clinical research seem increasingly unlikely to produce new therapies that will result in a step change in clinical outcomes. In this Commission, we set out our understanding of the clinical epidemiology and management of sepsis and then ask how the present approaches might be challenged to develop a new roadmap for future research.
774 citations
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Bernhard Nocht Institute for Tropical Medicine1, Public Health England2, World Health Organization3, Icahn School of Medicine at Mount Sinai4, University of North Carolina at Chapel Hill5, European Medicines Agency6, Peking Union Medical College7, Katholieke Universiteit Leuven8, National Institutes of Health9, University of Alabama at Birmingham10, University of Pittsburgh11, University of Saskatchewan12, University of Maryland, Baltimore13, Erasmus University Medical Center14, Center for Biologics Evaluation and Research15, Université Paris-Saclay16, Wageningen University and Research Centre17, Columbia University18, University of California, San Diego19, University of Texas Medical Branch20, Autonomous University of Barcelona21, Friedrich Loeffler Institute22, Li Ka Shing Faculty of Medicine, University of Hong Kong23, University of Iowa24, Kansas State University25, Tulane University26, University of York27, Geelong Football Club28, Beth Israel Deaconess Medical Center29
TL;DR: The findings of a World Health Organization expert working group that is developing animal models to test vaccines and therapeutic agents for the treatment of COVID-19, and their relevance for preclinical testing, are reviewed.
Abstract: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the aetiological agent of coronavirus disease 2019 (COVID-19), an emerging respiratory infection caused by the introduction of a novel coronavirus into humans late in 2019 (first detected in Hubei province, China). As of 18 September 2020, SARS-CoV-2 has spread to 215 countries, has infected more than 30 million people and has caused more than 950,000 deaths. As humans do not have pre-existing immunity to SARS-CoV-2, there is an urgent need to develop therapeutic agents and vaccines to mitigate the current pandemic and to prevent the re-emergence of COVID-19. In February 2020, the World Health Organization (WHO) assembled an international panel to develop animal models for COVID-19 to accelerate the testing of vaccines and therapeutic agents. Here we summarize the findings to date and provides relevant information for preclinical testing of vaccine candidates and therapeutic agents for COVID-19.
630 citations
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QIMR Berghofer Medical Research Institute1, Charité2, University of Alabama at Birmingham3, Charles University in Prague4, National Institutes of Health5, Paris Descartes University6, St. Michael's Hospital7, Istituto Giannina Gaslini8, University of Auckland9, Nanyang Technological University10, Cystic Fibrosis Trust11, European Medicines Agency12, University of Washington13, University of Wisconsin-Madison14, University of British Columbia15, Katholieke Universiteit Leuven16, Seattle Children's Research Institute17, Post Graduate Institute of Medical Education and Research18, University College Dublin19, University of Giessen20, University of Michigan21, Queen's University Belfast22, Johns Hopkins University23, University of Liverpool24, Woolcock Institute of Medical Research25, University of Toronto26, University of Cape Town27
TL;DR: Advances in clinical care have been multifaceted and include earlier diagnosis through the implementation of newborn screening programmes, formalised airway clearance therapy, and reduced malnutrition through the use of effective pancreatic enzyme replacement and a high-energy, high-protein diet.
427 citations
Authors
Showing all 604 results
Name | H-index | Papers | Citations |
---|---|---|---|
Richard H. Guy | 90 | 493 | 29136 |
Hubert G. M. Leufkens | 74 | 538 | 22557 |
Ernst R. Berndt | 73 | 305 | 25301 |
Sergio Bonini | 68 | 285 | 22128 |
Alessandro Aiuti | 62 | 264 | 17709 |
Hans-Georg Eichler | 61 | 263 | 10998 |
Aaron S. Kesselheim | 55 | 581 | 12726 |
Jean-Michel Dogné | 45 | 303 | 8009 |
Luca Pani | 44 | 220 | 6505 |
Martin Posch | 44 | 191 | 6642 |
Adrián LLerena | 43 | 226 | 6276 |
Julio Delgado | 43 | 263 | 8590 |
Jan A.J.M. Taminiau | 42 | 125 | 5892 |
Daniela Melchiorri | 42 | 83 | 5528 |
Guido Rasi | 37 | 109 | 3365 |